Influenza Vaccine in Lung Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Hayney, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205270
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

Research Question: How do antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation and healthy individuals?

Experimental Design: This interventional parallel group study will compare influenza vaccine induced immune responses in three groups: lung transplant patients, individuals waiting for lung transplantation and healthy individuals.

Current and Future Research Activities: Blood will be drawn for these measures of vaccine induced antibody response before and 2 to 4 weeks after immunization. Another blood draw will be obtained from up to 30 individuals from among the three groups for measures of T cell response to immunization. The third blood draw will be done during months 1 to 5 following influenza immunization. Genetic material (DNA) will be obtained from cells in the blood to look for genetic markers that may be associated with influenza vaccine response. Blood draws and immunization for the healthy participants will be done at the General Clinical Research Center (GCRC) or in the Clinical Research Facility in Rennebohm Hall. The blood draws for the pre-transplant and post-transplant patients will be coordinated with clinically indicated laboratory tests in order to avoid additional venipunctures. Influenza immunization is part of the routine clinical care of patients with lung disease, and only the immune response data will be considered part of the research study.


Condition Intervention
Influenza
Drug: Influenza vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influenza Vaccine in Lung Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Antibody response to influenza vaccine [ Time Frame: Each season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • T cell response to influenza vaccine antigens [ Time Frame: Each season for the first two seasons ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: December 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Influenza vaccine
    influenza vaccine 0.5 ml intramuscularly each season
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
  • Healthy adult

Exclusion Criteria:

  • Allergy to eggs
  • Moderate to severe febrile illness
  • Active treatment for acute rejection
  • Received season's influenza vaccine prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205270

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mary S Hayney, PharmD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Mary Hayney, Professor of Pharmacy, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205270     History of Changes
Other Study ID Numbers: 2004-0240
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Pre or post-lung transplant
Healthy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014